Regulation of TFA (Pdf to Save or Print) - Food Safety and Standards ...

2Risk Assessment Report on TFAs in Indian Diets submitted by National Institute ofNutrition, Hyderabad in October, 20094. On the request of FSSAI, NIN carried out a risk analysis of transfats in the Indiandiet. A summary of the findings of the report is as under:-(a) Not more than 10% (7% for those with cardiac problems) and 1% of totalenergy can be derived from saturated fat and TFA, respectively according to currentscientific research and WHO recommendations, if risk of cardio- vascular diseasehas to be kept at safe levels. It is important for population and individual health thatTFAs should be removed from the food supply and should be replaced by cisunsaturatedfats from vegetable oils rather than saturated fats from tropical oils andanimal fats.(b) In rural and urban India the fat consumption is around 20 and 30g /day,respectively, according to diet studies (National Consumption Survey data). If 10%TFA is permitted in vanaspati, a person consuming 2000Kcal derived from foodwhich contains 20 and 30g vanaspati/day will derive 0.9 and 1.35 % energy from theTFA. (This shows that even at 10% TFA level there is health risk at 30g of vanaspaticonsumption per day (which exceeds the 1% energy, which is the limit for TFArecommended by WHO).(c) Attempts to bring down the levels of TFAs in PHVOs by completehydrogenation or higher levels of hydrogenation will result in elevated melting pointand SFA content. This has to be viewed with caution as elevation of SFAs invanaspati obtained from complete hydrogenation would result in increase in % ofenergy derived from SFAs (not more than 7% of total energy is to be derived fromsaturated fat as recommended by WHO). Increase in intake of SFAs will lead toincrease in serum cholesterol levels and Low Density Lipoprotein (LDL) which arepotential risk factors for CHD.5. The World Health Assembly resolved in 2004 that elimination of TFA should be akey point for action by governments. WHO/FAO has recently completed an extensivereview of latest research on the links of TFA to CVD and diabetes and recommended thatall countries should take urgent regulatory steps to limit transfats in their diet so that cleardanger to heart health in vulnerable groups is avoided. According to a report in New

3England Journal of Medicine (Mozaffarian et al, 2006) consumption of transfats result inconsiderable potential harm with no benefit. National Academy of Sciences, USA hasconcluded that there is no safe level of TFA consumption, no recommended daily amountor tolerable upper limit as any incremental increase in TFA increases the risk of coronaryheart disease.6. The implications of replacing high TFA partially hydrogenated oil by substituteswere also considered by FSSAI. While the availability of alternative sources of fats is notlikely to be a problem, test results of the fatty acids profile in the market indicate thattechnological solutions are available for reducing trans fats to acceptable limits. Industrymay require a suitable time frame for adopting these practices and healthier alternatives.Support should be given to industry to communicate the healthier nature of its products toconsumers and also help small and medium sized enterprises to prepare for compliance.The vegetable oil industry should take the lead in this area.7. The experience of other countries who have introduced regulation to limit trans fatsindicate that Polyunsaturated fatty acids including alpha-linolenic (Omega 3) and linoleic(Omega 6) acids are also important components of a cholesterol lowering and morehealthful diet. However, the benefits depend to some degree on consuming anappropriate balance of these fatty acids. The goal, therefore, should be to replace, asmuch as possible, trans saturated fats with mono unsaturated fats and maintain adequateintake and appropriate balance of Omega 6 and Omega 3 polyunsaturated fatty acids.8. It is also necessary to consider appropriate modifications in the edible oilsregulations to encourage use of all available healthier alternatives. Further research onthese possibilities need to be undertaken so that available options are considered andappropriate regulations are developed.Current regulations for TFAs9. The PFA Rules, 1955 require that:-(a) The foods in which hydrogenated vegetable fats or bakery shortening is usedshall declare on the label that “Hydrogenated vegetable fats or bakeryshortening used-contains trans fats”.

5Proposed regulations under FSSAI13. The need was felt to regulate the TFAs in partially hydrogenated vegetable oils andthis issue was considered in the Third meeting of the Food Authority held on 26 thNovember, 2009 where it was recommended to fix a limit of not more than 10 percenttrans-fatty acids in partially hydrogenated vegetable oils. It was also recommended that anational consultation may also be organized to obtain feedback from consumers andindustry and the scientific community for implementation of the regulation.14. In view of above, National Institute of Nutrition, Hyderabad conducted a nationalconsultation by inviting participants representing all stakeholders on 29.01.2010 whichrecommended the following with regard to TFA limits :-(a) The TFA level in PHVO should be below 10% and should not exceed 10%.(b) Existing melting point regulation which is 31°C - 41°C for partially hydrogenatedvegetable oils, bakery shortening and margarines, interesterified vegetable fatand other fats made using vegetable oils should be removed in harmonizationwith Codex Standard.(c) Natural hard fractions like Palm Stearin should be included in list of edible oilsand fats in line with Codex Standard.(d) Mandatory labelling of TFA and saturated fat content for all edible oils and fatsshould be implemented.(e) PFA regulation must allow both chemical and enzymatic inter esterification.15. Thereafter the issue was considered in the meeting of Central Advisory Committeeand Scientific Committee of Food Authority which endorsed the recommendation of a limitof 10 % TFA in vanaspati to be brought down to 5% within a period of three years.16. An Expert Group constituted by FSSAI also deliberated on the need for fixing theTFA limit in vanaspati and recommended that level of TFA in Vanaspati / PHVO, be fixedat the level 10% maximum, to be brought down to 5% in 3 years. The Expert Group alsosuggested change in the regulations regarding melting point and enzymatic esterificationfor production of vanaspati for regulating trans fatty acids.

617. A large proportion of population in Indian sub continent is identified as geneticallypre-disposed to CVD. Consumption of vanaspati and TFA compound the risk of CVD inIndian population. It seems appropriate, therefore, that steps are taken in our country tominimize the TFA intake through dietary fat.18. Taking into account all the above mentioned inputs, the FSSAI proposes thefollowing :-(a)Level of TFA in Vanaspati / PHVO, be fixed at 10% maximum andbrought down to 5% in 3 years. A phasing in period may be given toindustry after the date of notification. A detailed review of the impact ofthe measure should be carried out by the end of 3 years to decidewhether further reduction can be attempted.(b)There are no substantial studies on detrimental effects of raising themelting point of vanaspati from current level of 41 0 to 51 0 or to removethe melting point limit altogether. On the other hand, it has beenargued that high melting point has no deleterious effect on health ordigestion. Nor do Codex standards prescribe an upper limit on meltingpoint. There is need to carry out studies for documenting the effects ofraising / removing the melting point limit on digestion and overallhealth. It is, therefore, proposed that presently status quo may bemaintained i.e. melting point of 41°C be retained or it be raised only tothe extent that would facilitate bringing down the TFA level to theabove limits.(c)There is also a need to look into the feasibility for laying down thelimits of Saturated Fatty Acids (SFAs) in vanaspati and other fats. Thisis being thought of because if the melting point is raised, it will lead toincrease in saturation of partially hydrogenated vegetable oils. WHOhad recommended that not more than 1% and not more than 10% ofenergy in diet be derived from TFAs and SFAs, respectively.(d)Enzymatic esterification for production of vanaspati for regulating transfatty acids can be considered. But it being a costly alternative, maytake time for implementation.

7(e)(f)(g)As regards permitting use of Palm Stearin in vanaspati, it also needs tobe looked into whether to allow its use or not as in our country PalmStearin is used in soap industry. However, there was no safety issue onits use and it is allowed in Codex standards with melting point of44°C - 52°C. Palm Stearin after interesterification with another liquidoil like rice bran oil, mustard oil, sunflower oil or soybean oil inappropriate ratio is shown to produce shortening similar to vanaspatiwith comparable functional properties and the product is completelyfree from trans fatty acids. However, Palm Stearin content may bepermitted only in interesterified fat and not approved for blending ofoils or to be used as such.There should be mandatory labelling of TFA & SFA content onvanaspati packs, edible oils or any other product containing TFA fromvanaspati sources. This is necessary to enable informed choice byconsumers.There is currently a limit on blending of more than two oils and aminimum requirement of 20% for each oil used for blending. Theselimits have been imposed to facilitate detection of adulteration. Thereis a demand for reviewing this restriction to facilitate greater use ofother oils by industry and facilitate balance in SFA : MUFA : PUFAcomponents.19. The above recommendations are likely to:(a) Contribute to decreasing / removing one of the risk factors andsignificantly improve the heart health of Indian citizens and save lives.(b) Reduce daily intake of transfats by Indian consumers of all age groupsto between 1% and 2% of energy intake consistent with current dietaryrecommendations, over a period of 3 years.(c) Those at the highest consumption level will benefit from themandatory reduction of industrially produced trans fats. Even those with lowconsumption will benefit. Even if small amounts of fat is consumed, if it isdevoid of TFA and contains unsaturated fatty acids, the population will standto benefit.

8(d) Promote the development of alternative supplies of more healthfulalternatives of trans fats.(e) Provide a level playing field to industry to compete on the basis of thesafety and healthy features of their products.20. Keeping in view the importance of the proposed measure in improving health andreducing the risk of cardiovascular disease to a large section of the population, FoodSafety and Standards Authority believes that the proposed measure should be widelydisseminated for feedback from all stakeholders. Those desirous of commenting on theproposed measure are invited to send their comments within 30 days from publishing ofthis note to Food Safety and Standards Authority. Thereafter, Food Safety and StandardsAuthority proposes to finalise the regulations for submission to the Government.Please send your comments to :Name : Dr. Dhir Singh, ADG(PFA)E.mail : adgpfa@nb.nic.inContact No. : 23237418Fax No. : 23220994